NCT02490280

Brief Summary

The purpose of this study is to investigate how healthy youth and adults' cortisol levels and other hormone levels relate to anxiety levels while they participate in a behavioral task called the Trier Social Stress Task. Data from these healthy participants will also be compared to those of anxious youth and adults collected as part of the in the Principal Investigator's ongoing study titled, "Child/Adolescent Anxiety Multimodal Extended Long-term Study (NA00035687)."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
Last Updated

July 3, 2015

Status Verified

July 1, 2015

Enrollment Period

2 years

First QC Date

July 1, 2015

Last Update Submit

July 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS), and Adult Versions (Client-ADIS)

    The C/P and Client-ADIS' are semi-structured diagnostic interviews used to assess symptoms of anxiety, depression, and behavioral issues. This interview will be administered by a trained staff member and will utilize information from both parents and children (if child is under 18 years of age) or from the adult participant (if the participant is 18 years of age or older). This interview will be used to determine the presence or absence of an anxiety disorder for participants in this study. The ADIS is administered one time because each participant only completes a single study visit.

    1 day

Study Arms (1)

Trier Social Stress Test

EXPERIMENTAL

Participants will be administered the Trier Social Stress Test (TSST). The TSST is the gold standard social stress test and involves speaking in front of confederate judges and completing arithmetic tasks. The task takes 10-15 minutes.

Behavioral: Trier Social Stress Test

Interventions

The TSST is the gold standard social stress test and involves speaking in front of confederate judges and completing arithmetic tasks. The task takes 10-15 minutes.

Trier Social Stress Test

Eligibility Criteria

Age11 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participant has no current psychiatric disorder
  • Participant has no past psychiatric disorder
  • Participant has no major medical disorder
  • Participant is not currently receiving psychological or psychopharmacological treatment (medication) for any psychological disorder
  • Participant is between the ages 11 and 34

You may not qualify if:

  • Participant has or has had psychiatric disorder or medical condition contraindicating study participation
  • Participant is pregnant
  • Participant is not an English speaker
  • Participant has a visual, motor, or hearing problem that would affect participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Golda S Ginsburg, Ph.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 3, 2015

Study Start

April 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 3, 2015

Record last verified: 2015-07

Locations